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Student Regulatory Affairs Assistant 526
2 months ago
Onsite
Regulatory Affairs
About the jobProductLife Group is looking for a skilled and enthusiastic student living in Denmark, who can work approximately fifteen (15) hours per week from the client’s offices in Valby. Full training will be provided. The activities may include the following tasks:
Responsibilities- RA archive management in the headquarters in Valby in line with compliance (GXP, internal SOPs and company policies).
- Receiving incoming documents, indexing those, electronic registering/archiving, and physical filing of paper documents.
- Locating archived documents upon request (in case of inspections or audits) and providing those to the requesting department.
- Indexing and archiving documents once they are returned.
- Cleaning documents in line with the documentation retention limits.
- Managing special projects related to product sales, ensuring all relevant RA documents are sent to the buyer and removed from the archive.
- Archiving incoming documents if the company acquires products.
- Ordering boxes, binders, stickers, labels, and pallets needed for archiving tasks.
- Managing incoming post.
- Assisting in the preparation of Standard Operating Procedures (SOPs) and Working Practice Documents (WPDs).
- Assisting in the management of ProductLife Quality Management System.
- Participating in training as required for ProductLife staff.
- Complying with the company’s policies and procedures to meet statutory, quality, and business requirements within the overall strategy and objectives.
- Currently studying for a bachelor’s or master’s degree related to Pharmacy, Pharmaceutical Design, Biology, Chemistry, etc.
- Excellent organizational and interpersonal skills.
- Ability to work well within a team.
- Process-oriented with good attention to detail.
- Effective oral and written communication skills.
- Good computer skills and the ability to learn appropriate software.
- Good understanding of regulatory tracking database software, eDMS, MS Word, MS Excel.
- Good English language and grammar skills (written fluency a must, verbal fluency preferred); at least one Nordic language mastered is a plus.
